K Number

Device Name

ONTRAK TESTCUP II AND ONSITE CUPKIT

Manufacturer

VARIAN INC

Date Cleared

2004-01-20

(34 days)

Product Code

DKZ

Regulation Number

862.3100

Intended Use

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites in urine at or above the stated cutoff concentrations. Cutoff Concentrations: Amphetamines: 1000 ng/mL Benzodiazepines: 200 ng/mL Cocaine metabolite: 300 ng/mL Methamphetamine: 500 ng/mL Morphine: 300 ng/mL Morphine (M2K): 2000 ng/mL Phencyclidine (PCP): 25 ng/mL Tetrahydrocannabinols (THC): 50 ng/mL TesTcup II and CupKit products provide only a preliminary analytical test result. A more reliable analytical method must be used in order to obtain a confirmed analytical result.

Device Description

The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ 9 -THC-9-carboxylic acid 50 ng/mL). The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band. When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative" result is the absence of a blue band). An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K001421, K994017, K983174, K994164

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunoassay based on chemical reactions and visual interpretation of bands, with no mention of computational analysis, algorithms, or learning processes.

Therapeutic

No.
This device is an in vitro diagnostic test for detecting drugs or drug metabolites in urine, which is used for diagnostic purposes, not for treating or preventing disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the products are "in vitro diagnostics tests." The "Device Description" section also refers to them as "in vitro diagnostic tests."

SaMD (Software as a Medical Device)

The device is an in vitro diagnostic test that relies on chemical reactions and physical components (test cup, profile card, membrane) to detect drugs in urine. It does not describe any software component that performs a medical device function.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states that the TesTcup II and CupKit products are "in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites in urine". This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body to detect diseases, conditions, or the presence of substances.
Device Description: The description details a test that uses biological samples (urine) and reagents to detect the presence of specific substances (drugs or drug metabolites). This is characteristic of an in vitro diagnostic test.
Performance Studies: The document describes performance studies conducted to evaluate the accuracy, precision, and specificity of the device using clinical specimens. This type of testing is required for IVD devices to demonstrate their reliability and validity for their intended use.

Therefore, based on the provided information, the TesTcup II and CupKit products are clearly identified and described as in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

OnTrak TesTcup II and OnSite Cupkit assays are intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ9-THC-9-carboxylic acid 50 ng/mL).

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for detection of drugs or drug metabolites in urine at or above the stated cutoff concentrations.
Cutoff Concentrations:
Amphetamines: 1000 ng/mL
Benzodiazepines: 200 ng/mL
Cocaine metabolite: 300 ng/mL
Methamphetamine: 500 ng/mL
Morphine: 300 ng/mL
Morphine (M2K): 2000 ng/mL
Phencyclidine (PCP): 25 ng/mL
Tetrahydrocannabinols (THC): 50 ng/mL

TesTcup II and CupKit products provide only a preliminary analytical test result. A more confirmed analytical method must be used in order to obtain a confirmed analytical result.

Product codes (comma separated list FDA assigned to the subject device)

DKZ, JXM, DIO, DJG, LCM, LDJ, DJC

Device Description

The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ9-THC-9-carboxylic acid 50 ng/mL).
The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber.
Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band. When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative" result is the absence of a blue band).
An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Professional use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Precision: The precision of TesTcup II and CupKit was determined by three operators across three different days, who tested 63 replicates on two lots using contrived specimens containing drugs or drug metabolites at various concentrations. The drug or drug metabolites were spiked into negative human urine pool and assayed by GC/MS.
Accuracy: TesTcup II and CupKit was evaluated in a SAMHSA certified laboratory using clinical specimens. The clinical negative samples were screened negative by an automated immunoassay and reported as negative according to SAMHSA guidelines. Clinical specimens screened positive by an automated immunoassay. Some samples were diluted with negative human urine to achieve the appropriate test range.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Study:
Amphetamine (Cutoff = 1000 ng/ml):
Lot 1: 0 ng/ml (0% +), 250 ng/ml (0% +), 500 ng/ml (12.7% +), 750 ng/ml (93.6% +), 1250 ng/ml (100% +), 1500 ng/ml (100% +)
Lot 2: 0 ng/ml (0% +), 250 ng/ml (0% +), 500 ng/ml (4.8% +), 750 ng/ml (88.9% +), 1250 ng/ml (100% +), 1500 ng/ml (100% +)

Morphine (Cutoff = 2000 ng/ml):
Lot 1: 0 ng/ml (0% +), 500 ng/ml (0% +), 1000 ng/ml (6.3% +), 1500 ng/ml (80.9% +), 2500 ng/ml (100% +), 3000 ng/ml (100% +)
Lot 2: 0 ng/ml (0% +), 500 ng/ml (0% +), 1000 ng/ml (0% +), 1500 ng/ml (31.7% +), 2500 ng/ml (100% +), 3000 ng/ml (100% +)

PCP (Cutoff = 25 ng/ml):
Lot 1: 0 ng/ml (0% +), 6.25 ng/ml (0% +), 12.5 ng/ml (0% +), 18.75 ng/ml (4.7% +), 31.25 ng/ml (95.2% +), 37.5 ng/ml (100% +)
Lot 2: 0 ng/ml (0% +), 6.25 ng/ml (0% +), 12.5 ng/ml (0% +), 18.75 ng/ml (6.3% +), 31.25 ng/ml (100% +), 37.5 ng/ml (100% +)

Benzodiazepines (Cutoff = 200 ng/ml):
Lot 1: 0 ng/ml (0% +), 50 ng/ml (0% +), 100 ng/ml (6.3% +), 150 ng/ml (49.2% +), 250 ng/ml (100% +), 300 ng/ml (100% +)
Lot 2: 0 ng/ml (0% +), 50 ng/ml (0% +), 100 ng/ml (22.2% +), 150 ng/ml (46% +), 250 ng/ml (100% +), 300 ng/ml (100% +)

Cocaine (Cutoff = 300 ng/ml):
Lot 1: 0 ng/ml (0% +), 75 ng/ml (0% +), 150 ng/ml (55.6% +), 225 ng/ml (100% +), 375 ng/ml (100% +), 450 ng/ml (100% +)
Lot 2: 0 ng/ml (0% +), 75 ng/ml (0% +), 150 ng/ml (19% +), 225 ng/ml (93.7% +), 375 ng/ml (100% +), 450 ng/ml (100% +)

THC (Cutoff = 50 ng/ml):
Lot 1: 0 ng/ml (0% +), 12.5 ng/ml (0% +), 25 ng/ml (0% +), 37.5 ng/ml (0% +), 62.5 ng/ml (96.8% +), 75 ng/ml (100% +)
Lot 2: 0 ng/ml (0% +), 12.5 ng/ml (0% +), 25 ng/ml (0% +), 37.5 ng/ml (9.5% +), 62.5 ng/ml (100% +), 75 ng/ml (100% +)

Morphine (Cutoff = 300 ng/ml):
Lot 1: 0 ng/ml (0% +), 75 ng/ml (0% +), 150 ng/ml (0% +), 225 ng/ml (17.5% +), 375 ng/ml (100% +), 450 ng/ml (100% +)
Lot 2: 0 ng/ml (0% +), 75 ng/ml (0% +), 150 ng/ml (0% +), 225 ng/ml (1.6% +), 375 ng/ml (100% +), 450 ng/ml (100% +)

Methamphetamine (Cutoff = 500 ng/ml):
Lot 1: 0 ng/ml (0% +), 125 ng/ml (0% +), 250 ng/ml (6.3% +), 375 ng/ml (79.4% +), 625 ng/ml (100% +), 750 ng/ml (100% +)
Lot 2: 0 ng/ml (0% +), 125 ng/ml (0% +), 250 ng/ml (0% +), 375 ng/ml (66.7% +), 625 ng/ml (100% +), 750 ng/ml (100% +)

Accuracy Study (Comparison with Reference Method (GC/MS)):
THC (Cutoff = 50 ng/ml):
Negative Samples: 0 tested positive (+) , 100 tested negative (-)
Near Cutoff (75% to 100% of Cutoff): 13 tested positive (+), 0 tested negative (-)
Near Cutoff (100% to 125% of Cutoff): 6 tested positive (+), 0 tested negative (-)

125% of cutoff: 31 tested positive (+), 0 tested negative (-)

Cocaine (Cutoff = 300 ng/ml):
Negative Samples: 0 tested positive (+), 100 tested negative (-)
Near Cutoff (75% to 100% of Cutoff): 6 tested positive (+), 1 tested negative (-)
Near Cutoff (100% to 125% of Cutoff): 7 tested positive (+), 1 tested negative (-)

125% of cutoff: 35 tested positive (+), 0 tested negative (-)

PCP (Cutoff = 25 ng/ml):
Negative Samples: 0 tested positive (+), 100 tested negative (-)
Near Cutoff (75% to 100% of Cutoff): 0 tested positive (+), 8 tested negative (-)
Near Cutoff (100% to 125% of Cutoff): 0 tested positive (+), 0 tested negative (-)

125% of cutoff: 37 tested positive (+), 0 tested negative (-)

Amphetamine (Cutoff = 1000 ng/ml):
Negative Samples: 0 tested positive (+), 100 tested negative (-)
Near Cutoff (75% to 100% of Cutoff): 6 tested positive (+), 8 tested negative (-)
Near Cutoff (100% to 125% of Cutoff): 5 tested positive (+), 0 tested negative (-)

125% of cutoff: 29 tested positive (+), 2 tested negative (-)
*GC/MS values for these samples were 1569 ng/mL and 1776 ng/mL.

Methamphetamine (Cutoff = 500 ng/ml):
Negative Samples: 0 tested positive (+), 100 tested negative (-)
Near Cutoff (75% to 100% of Cutoff): 3 tested positive (+), 2 tested negative (-)
Near Cutoff (100% to 125% of Cutoff): 5 tested positive (+), 0 tested negative (-)

125% of cutoff: 48 tested positive (+), 0 tested negative (-)

Morphine (Cutoff = 300 ng/ml):
Negative Samples: 0 tested positive (+), 100 tested negative (-)
Near Cutoff (75% to 100% of Cutoff): 7 tested positive (+), 0 tested negative (-)
Near Cutoff (100% to 125% of Cutoff): 8 tested positive (+), 0 tested negative (-)

125% of cutoff: 46 tested positive (+), 0 tested negative (-)

Morphine (M2K) (Cutoff = 2000 ng/ml):
Negative Samples: 0 tested positive (+), 100 tested negative (-)
Near Cutoff (75% to 100% of Cutoff): 7 tested positive (+), 3 tested negative (-)
Near Cutoff (100% to 125% of Cutoff): 5 tested positive (+), 0 tested negative (-)

125% of cutoff: 35 tested positive (+), 0 tested negative (-)

Benzodiazepines (Cutoff = 200 ng/ml):
Negative Samples: 0 tested positive (+), 100 tested negative (-)
Near Cutoff (75% to 100% of Cutoff): 6 tested positive (+), 0 tested negative (-)
Near Cutoff (100% to 125% of Cutoff): 8 tested positive (+), 0 tested negative (-)

125% of cutoff: 50 tested positive (+), 0 tested negative (-)

Comparison with predicate device (Overall percent agreement):
THC: 98%
Cocaine: 100%
PCP: 99%
Amphetamines: 97%
Methamphetamine: 100%
Morphine: 100%
Morphine 2000 (M2K): 96%
Benzodiazepines: 100%

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. Precision results are given in percentages of positive and negative results. Accuracy results are given in counts of positive/negative results per concentration range. Overall percent agreement is provided for comparison with predicate devices.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

OnTrak TesTcup® 501, K001421, OnTrak TesTcup 5 M2K, K994017, OnTrak TesTstik BNZ, K983174, OnTrak TesTstik® 2 COC/THC, K994164

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Summary

510(k) Summary
Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

| 1) Submitter name, address, contact | Varian, Inc.
25200 Commercentre Drive
Lake Forest, CA 92630
(949) 770-9381

Contact: Lorna Gamboa |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 15, 2003 |

| 2) Device Name | Proprietary Name: OnTrak TesTcup® II and OnSite CupKit™

Panel: Toxicology |

----------------	----------------------------------------------------------------------------------

Classification Name:	Product Code	Regulation Number
Enzyme Immunoassay, Amphetamine	DKZ	862.3100
Enzyme Immunoassay, Benzodiazepine	JXM	862.3170
Enzyme Immunoassay, Cocaine and Cocaine Metabolite	DIO	862.3250
Enzyme Immunoassay, Opiate	DJG	862.3650
Enzyme Immunoassay, Phencyclidine	LCM	Unclassified
Enzyme Immunoassay, Cannabinoids	LDJ	862.3870
Thin Layer Chromatography, Methamphetamine	DJC	862.3610

| 3) Predicate Device | We claim substantial equivalence to these currently marketed devices:

OnTrak TesTcup® 501, K001421, 7/12/2000
OnTrak TesTcup 5 M2K, K994017, 1/27/2000
OnTrak TesTstik BNZ, K983174, 11/18/98
OnTrak TesTstik® 2 COC/THC, K994164, 4/13/2000 |

---------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

4) Device Description	The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ 9 -THC-9-carboxylic acid 50 ng/mL).
-----------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

4) Device Description

-----------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membranc in the test chamber.

| | Urine is collected directly in the test cup provided. The drug profile card is placed
in the samples by inserting it into the lid holder, then securing the lid onto the cup.
Urine is drawn in the profile card by capillary action and reacts with antibody-
coated microparticles and drug conjugate present on the membrane. In the
absence of drug, the antibody is free to interact with the drug conjugate, causing
the formation of a blue band. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | When drug is present in the specimen, it binds to the antibody-coated
microparticles. If sufficient drug is present, the microparticles are inhibited from
binding the drug conjugate and no blue band is formed at the result window. A
preliminary positive ("non-negative" result is the absence of a blue band). |
| | An additional antibody/antigen reaction occurs at the "VALID" area.
The
"VALID" blue band forms when antibodies, which are imbedded in the reagent
membrane, interact with and bind to the antigen on the blue microparticles. |
| 5) Statement of
Intended Use | OnTrak TesTcup II and OnSite Cupkit assays are intended for professional use for
the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL),
benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine
300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine
(morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP
(phencyclidine 25 ng/mL), and THC (11-nor-A9-THC-9-carboxylic acid 50
ng/mL). |
| 6) Technological
Characteristics | See "Summary of Testing" on the following pages. |
| Substantial
Equivalence | The TesTcup II and CupKit devices have the same intended use and incorporate
the same fundamental scientific technology as the predicate devices. |

510(k) Summary (continued)

Summary of testing

Precision

The precision of TesTcup II and CupKit was determined by three operators across three different days, who tested 63 replicates on two lots using contrived specimens containing drugs or drug metabolites at various concentrations. The drug or drug metabolites were spiked into negative human urine pool and assayed by GC/MS. The results are summarized in the tables below.

All lots are required minimally to perform with a greater than 95% confidence level that negative results will be attained with drugs at 25% (1/4 X) of their respective cutoff concentrations, and a greater than 95% confidence level that positive results will be attained with drugs at 150% (1/-1/2 X) of their respective cutoff concentrations.

Amphetamine (ng/ml)	Precision Results (%)
Cutoff = 1000 ng/ml	Lot 1		Lot 2
	+	-	+	-
0	0	100	0	100
250	0	100	0	100
500	12.7	87.3	4.8	95.2
750	93.6	6.4	88.9	11.1
1250	100	0	100	0
1500	100	0	100	0

| Morphine (ng/ml)

Cutoff = 2000 ng/ml	Precision Results (%)
	Lot 1		Lot 2
	+	-	+	-
0	0	100	0	100
500	0	100	0	100
1000	6.3	93.7	0	100
1500	80.9	19.1	31.7	68.3
2500	100	0	100	0
3000	100	0	100	0

| PCP (ng/ml)

Cutoff = 25 ng/ml	Lot 1		Lot 2
	+	-	+	-
0	0	100	0	100
6.25	0	100	0	100
12.5	0	100	0	100
18.75	4.7	95.3	6.3	93.7
31.25	95.2	4.8	100	0
37.5	100	0	100	0

| Benzodiazepines (ng/ml)

Cutoff = 200 ng/ml	Precision Results (%)
	Lot 1		Lot 2
	+	-	+	-
0	0	100	0	100
50	0	100	0	100
100	6.3	93.7	22.2	77.8
150	49.2	50.8	46	54
250	100	0	100	0
300	100	0	100	0

| Cocaine (ng/ml)
Cutoff = 300 ng/ml | Precision Results (%)
Lot 1 | | Lot 2 | |
|---------------------------------------|--------------------------------|------|-------|-----|
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 75 | 0 | 100 | 0 | 100 |
| 150 | 55.6 | 44.4 | 19 | 81 |
| 225 | 100 | 0 | 93.7 | 6.3 |
| 375 | 100 | 0 | 100 | 0 |
| 450 | 100 | 0 | 100 | 0 |

THC (ng/ml)	Precision Results (%)
Cutoff = 50 ng/ml	Lot 1		Lot 2
	+	-	+	-
0	0	100	0	100
12.5	0	100	0	100
25	0	100	0	100
37.5	0	100	9.5	90.5
62.5	96.8	3.2	100	0
75	100	0	100	0

| Morphine (ng/ml)

Cutoff = 300 ng/ml	Precision Results (%)
Lot 1		Lot 2
	+	-	+	-
0	0	100	0	100
75	0	100	0	100
150	0	100	0	100
225	17.5	82.5	1.6	98.4
375	100	0	100	0
450	100	0	100	0

| Methamphetamine(ng/ml)
Cutoff = 500 ng/ml | Precision Results (%)
Lot 1 | | Lot 2 | |
|----------------------------------------------|--------------------------------|------|-------|------|
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 125 | 0 | 100 | 0 | 100 |
| 250 | 6.3 | 93.7 | 0 | 100 |
| 375 | 79.4 | 20.6 | 66.7 | 33.3 |
| 625 | 100 | 0 | 100 | 0 |
| 750 | 100 | 0 | 100 | 0 |

Specificity

The following structurally similar compounds for amphetamine, benzodiazepines, cocaine, methamphetamine, morphine, PCP and THC were tested for cross reactivity with TesTcup II/CupKit. memailling, its primered in normal human urine. The results are expressed as that amount of the compound capable of giving a result equivalent to the cutoff for that assay.

Amphetamine-related Compounds	Minimum Concentration Required to give a positive result (ng/ml)
d-Amphetamine	500
Methylenedioxyamphetamine (MDA)	5000
l-Amphetamine	25,000
β-Phenethylamine	100,000
d,l-Phenylpropanolamine	100,000
d,l-Methamphetamine	>100,000

| Benzodiazepines-related Compounds | Minimum Concentration Required to give a
positive result (ng/ml) |
|-----------------------------------|---------------------------------------------------------------------|
| 7-Aminoflunitrazepam | 100 |
| Bromazepam | 100 |
| Didesethylflurazepam | 100 |
| 7-Aminonitrazepam | 100 |
| α-Hydroxyalprazolam | 100 |
| α-Hydroxytriazolam | 100 |
| Norfludiazepam | 100 |
| Nordiazepam | 100 |
| Temazepam | 100 |
| Clonazepam | 250 |
| Lorazepam | 250 |
| Chlorazepate | 250 |
| Flurazepam | 250 |
| Desmethylflunitrazepam | 250 |
| Alprazolam | 250 |
| Diazepam | 250 |
| Demoxepam | 500 |

Triazolam	500
Hydroxyethylflurazepam	1000
Flunitrazepam	1000
Chlordiazepoxide	2000

| Cocaine-related Compounds | Minimum Concentration Required to give a
positive result (ng/ml) |
|---------------------------|---------------------------------------------------------------------|
| Cocaine HCl | >100,000 |

| Methamphetamine-related Compounds | Minimum Concentration Required to give a
positive result (ng/ml) |
|-------------------------------------------|---------------------------------------------------------------------|
| Propylhexedrine | 1000 |
| d,l-Methamphetamine | 2000 |
| 3,4-Methylenedioxymethamphetamine (MDMA) | 2000 |
| l-Methamphetamine | 3000 |
| Fenfluramine | 5000 |
| p-Hydroxymethamphetamine | 5000 |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 10,000 |
| d-Amphetamine | 25,000 |
| l-Phenylephrine | 50,000 |
| d,l-Ephedrine | 50,000 |
| Ranitidine | 50,000 |
| β-Phenethylamine | 50,000 |
| d,l-Amphetamine | 50,000 |
| 3,4-Methylenedioxyamphetamine (MDA) | 100,000 |
| l-Amphetamine | >100,000 |

| Morphine-300-related Compounds | Minimum Concentration Required to give a
positive result (ng/ml) |
|--------------------------------|---------------------------------------------------------------------|
| Codeine | 250 |
| Ethyl morphine HCl | 250 |
| Dihydrocodeine bitartrate | 500 |
| 6-Acetylmorphine | 500 |
| Hydrocodone bitartrate | 500 |
| Morphine-3-glucuronide | 500 |
| Hydromorphone HCl | 1000 |
| Nalorphine | 2000 |
| Thebaine | 3000 |
| Levorphanol | 25,000 |
| Rifampin | 50,000 |
| N-Norcodeine HCl | 100,000 |
| Oxycodone | 100,000 |
| Meperidine | 100,000 |
| Atropine | >100,000 |
| THC-related Compounds | Minimum Concentration Required to give a
positive result (ng/ml) |

11-hydroxy - Δ° THC

50,000

Morphine-2000-related Compounds	Minimum Concentration Required to give a positive result (ng/ml)
Codeine	2000
6-Acetylmorphine	2000
Ethyl morphine HCl	3000
Dihydrocodeine bitartrate	3000
Morphine-3-glucuronide	3000
Hydrocodone bitartrate	10,000
Hydromorphone HCl	10,000
Nalorphine	25,000
Thebaine	50,000
Levorphanol	>100,000
Rifampin	>100,000
Oxycodone	>100,000

Cross-Reactivity with Additional Drugs

The following compounds were tested at 100,000 ng/ml and found not to cross-react with the (OnTrak TesTcup II or Onsite CupKit) assays (except as noted).

Acetominophen Acetylsalicylic acid 6-Acetylmorphine (except morphine assay) Alprazolam (except benzodiazepine assay) 7-Aminoflunitrazepam (except benzodiazepine assay) 7-Aminonitrazepam (except benzodiazepine assay) d.l-Amphetamine (except amphetamine and methamphetamine assay) d-Amphetamine (except amphetamine and methamphetamine assay) I-Amphetamine (except amphetamine and methamphetamine assay) Atropine Benzocaine Benzphetamine Bromazepam (except benzodiazepine assay) (±) Brompheniramine Buprenorphine Bupropion Chlorazepate (except benzodiazepine assay) Chlordiazepoxide (except benzodiazepine assay) Clonazepam (except benzodiazepine assav) Cocaine HCI (except Cocaine assay) Codeine (except morphine assay) Demoxepam (except benzodiazepine assay) Desmethylflunitrazepam (except benzodiazepine assay) Dextromethorphan Dextrorphan Diazepam (except benzodiazepine assay) Didesethylflurazepam (except benzodiazepine assay) Dihydrocodeine bitartrate (except morphine assay) Diphenhydramine d, l-Methamphetamine (except methamphetamine assay)

Doxylamine d.l-Ephedrine (except methamphetamine assay) Ethyl morphine HCI (except morphine assay) Fenfluramine (except methamphetamine assay) Fenoprofen Flunitrazepam (except benzodiazepine assay) Flurazepam (except benzodiazepine assay) Gemfibrozil Hydrochlorothiazide Hydrocodone bitartrate (except morphine assay) Hydromorphone HCl (except morphine assay) a-Hydroxyalprazolam (except benzodiazepine assay) Hydroxybupropion Hydroxyethylflurazcpam (except benzodiazepine assay) >-Hydroxymethamphetamine (except methamphetamine assay) a-Hvdroxytriazolam (except benzodiazepine assay) Ibuprofen Ketamine Lansoprazole Levorphanol (except morphine assay) Lidocaine Lorazepam (except benzodiazepine assay) MDA (except amphetamine and methamphetamine assay) MDEA (except methamphetamine assay) MDMA (except methamphetamine assay) Meperidine (except morphine assay) d-Methamphetamine (except methamphetamine assay) d, l-Methamphetamine (except amphetamine and methamphetamine assay) I-Methamphetamine (except methamphetamine assay) Methylphenidate Morphine-3-glucuronide (except morphine assay) Nalorphine (except morphine assay) Naproxen N-Norcodeine HCl (except morphine assay) Nordiazepam (except benzodiazepine assay) Norfludiazepam (except benzodiazepine assay) Oxycodone (except morphine assay) B-Phenethylamine (except amphetamine and methamphetamine assay) /-Phenvlephrine (except methamphetamine assay) d.l-Phenvlpropanolamine (except amphetamine assay) Propylhexedrine (except methamphetamine assay) Quinidine Quinine Ranitidine (except methamphetamine assay) Rifampin (except morphine assay) Temazepam (cxcept benzodiazepine assay) Thebaine (except morphine assay) 11-hydroxy - A THC (except THC assay) A THC Triazolam (except benzodiazepine assay)

Accuracy

TesTcup II and CupKit was evaluated in a SAMHSA certified laboratory using clinical specimens. The clinical negative samples were screened negative by an automated immunoassay and reported as negative according to SAMHSA guidelines. Clinical specimens screened positive by an automated immunoassay accessible to brinners goal binnel. Some samples were diluted with negative human urine to achieve the appropriate test range. Results are summarized below.

| THC
Cutoff = 50
ng/ml | | Negative
Samples | Near Cutoff | | > 125% of cutoff |
|-----------------------------|---|---------------------|--------------------------|---------------------------|------------------|
| | | | 75% to 100% of
Cutoff | 100% to 125% of
cutoff | |
| | + | 0 | 13 | 6 | 31 |
| | - | 100 | 0 | 0 | 0 |

Comparison with Reference Method (GC/MS):

| Cocaine
Cutoff = 300
ng/ml | Negative
Samples | GC/MS Values (ng/ml) | | |
|----------------------------------|---------------------|--------------------------|---------------------------|------------------|
| | | Near Cutoff | | > 125% of cutoff |
| + | 0 | 75% to 100% of
Cutoff | 100% to 125% of
cutoff | > 125% of cutoff |
| | | 6 | 7 | 35 |
| - | 100 | 1 | 1 | 0 |

| PCP
Cutoff = 25
ng/ml | | Negative
Samples | GC/MS Values (ng/ml) | | > 125% of cutoff |
|-----------------------------|---|---------------------|--------------------------|---------------------------|------------------|
| | | | Near Cutoff | | |
| | + | 0 | 75% to 100% of
Cutoff | 100% to 125% of
cutoff | 37 |
| | - | 100 | 8 | 0 | 0 |

| Amphetamine
Cutoff = 1000
ng/ml | | Negative
Samples | GC/MS Values (ng/ml) | | |
|---------------------------------------|--|---------------------|--------------------------|---------------------------|------------------|
| | | | Near Cutoff | | |
| | | | 75% to 100% of
Cutoff | 100% to 125% of
cutoff | > 125% of cutoff |
| + | | 0 | 6 | 5 | 29 |
| - | | 100 | 8 | 0 | 2* |

*GC/MS values for these samples were 1569 ng/mL and 1776 ng/mL.

| Methamphetamine
Cutoff = 500
ng/ml | | Negative
Samples | GC/MS Values (ng/ml)
Near Cutoff | | > 125% of cutoff |
|------------------------------------------|---|---------------------|-------------------------------------|---------------------------|------------------|
| | | | 75% to 100% of
Cutoff | 100% to 125% of
cutoff | |
| | + | 0 | 3 | 5 | 48 |
| | - | 100 | 2 | 0 | 0 |

| Morphine
Cutoff = 300
ng/ml | Negative
Samples | GC/MS Values (ng/ml) | | |
|-----------------------------------|---------------------|--------------------------|---------------------------|------------------|
| | | Near Cutoff | | > 125% of cutoff |
| | | 75% to 100% of
Cutoff | 100% to 125% of
cutoff | |
| + | 0 | 7 | 8 | 46 |
| - | 100 | 0 | 0 | 0 |

| Morphine
(M2K)
Cutoff = 2000
ng/ml | | Negative
Samples | GC/MS Values (ng/ml)
Near Cutoff | | > 125% of cutoff |
|---------------------------------------------|--|---------------------|-------------------------------------|---------------------------|------------------|
| | | | 75% to 100% of
Cutoff | 100% to 125% of
cutoff | |
| + | | 0 | 7 | 5 | 35 |
| - | | 100 | 3 | 0 | 0 |

| Benzodiazepines
Cutoff = 200
ng/ml | Negative
Samples | GC/MS Values (ng/ml)
Near Cutoff | | > 125% of cutoff |
|------------------------------------------|---------------------|-------------------------------------|---------------------------|------------------|
| | | 75% to 100% of
Cutoff | 100% to 125% of
cutoff | |
| + | 0 | 6 | 8 | 50 |
| - | 100 | 0 | 0 | 0 |

Comparison with predicate device

All of the above clinical specimens were also tested by, and results compared to, OnTrak TesTcup and OnTrak TesTstik. Results are summarized below.

THC		TesTstik 2
Overall percent agreement = 98%		+	-
New Test	+	47	3
	-	0	100

Cocaine
Overall percent agreement = 100%
New Test	TesTstik 2 +	TesTstik 2 -
+	48	0
-	0	102

| PCP

Overall percent agreement = 99%		TesTstik 2
		+	-
New Test
(CupKit)	+	41	1
	-	0	108

Amphetamines		TesTstik 2
Overall percent agreement = 97%		+	-
New Test	+	36	4
	-	0	110

| Methamphetamine

Overall percent agreement = 100%		TesTstik 2
		+	-
New Test	+	56	0
	-	0	102

| Morphine

Overall percent agreement = 100%		TesTstik 2
New Test	+	+	-
	-	61	0
		0	100

| Morphine 2000 (M2K)

Overall percent agreement = 96%		TesTstik 2
New Test	+	+	-
	-	0	103
	+	41	6

| Benzodiazepines

Overall percent agreement = 100%		TesTstik 2
		+	-
New Test	+	64	0
	-	0	100

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 0 2004

Ms. Lorna Gamboa Regulatory Affairs Manager Varian, Inc. 25200 Commercentre Drive Lake Forest, CA 92630

K033902 Re:

Trade/Device Name: On Trak TesTcup® II and OnSite CupKit™ Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: January 13, 2004 Received: January 14, 2004

Dear Ms. Gamboa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass suace in to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, ateres, provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 out all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Indications for Use Statement

K033902 510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: __ OnTrak TesTcup® II and OnSite CupKit™_________________________________________________________________________________________________________________________

Indications for Use:

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for t es reap if and Capitiv of drugs or drug metabolites in urine at or above the stated cutoff concentrations.

Cutoff Concentrations:

Amphetamines:	1000 ng/mL	Morphine:	300 ng/mL
Benzodiazepines:	200 ng/mL	Morphine (M2K):	2000 ng/mL
Cocaine metabolite:	300 ng/mL	Phencyclidine (PCP):	25 ng/mL
Methamphetamine:	500 ng/mL	Tetrahydrocannabinols (THC):	50 ng/mL

TesTcup II and CupKit products provide only a preliminary analytical test result. A more res reap it and Caprevical method must be used in order to obtain a confirmed analytical result.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

ileuk Cule

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KO33102 510(k) _______________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use